Alveolar Childhood RhabdomyosarcomaNCT01496573
Biomarkers in Tumor Tissue Samples From Younger Patients With Rhabdomyosarcoma
An observational study of Alveolar Childhood Rhabdomyosarcoma and Childhood Rhabdomyosarcoma, run by Children's Oncology Group at 1 site in United States.
Trial summary
This research trial studies biomarkers in tumor tissue samples from younger patients with rhabdomyosarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alveolar Childhood Rhabdomyosarcoma, Childhood Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma
- What is being tested?
- laboratory biomarker analysis
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma
Who may be able to join
- Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma specimens from the Children Oncology Group (COG) tumor microarrays (TMAs)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Monrovia, California, 91006-3776
About this study
Official title: Observational - CRKL Expression at the Protein Level in Rhabdomyosarcoma Tumors by Tissue Microarray (TMA)
This research trial studies biomarkers in tumor tissue samples from younger patients with rhabdomyosarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer
Read the detailed description
PRIMARY OBJECTIVES:
- To demonstrate CRKL expression at the protein level in rhabdomyosarcoma tumors by tissue microarray (TMA).
OUTLINE:
Archived tumor tissue samples are analyzed for CRKL expression.
- Conditions
- Alveolar Childhood Rhabdomyosarcoma, Childhood Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma
- Being tested
- laboratory biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Basic science (biomarker analysis) | Archived tumor tissue samples are analyzed for CRKL expression. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRKL expression at the protein level
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Childhood RhabdomyosarcomaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lee Helman, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496573
- Sponsor's protocol ID
- ARST12B4
- Other IDs
- NCI-2012-00094
- Status last verified
- May 2016
- First submitted
- 16 Dec 2011
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational - CRKL Expression at the Protein Level in Rhabdomyosarcoma Tumors by Tissue Microarray (TMA)
- ClinicalTrials.gov ID
- NCT01496573
- Acronym / sponsor ID
- ARST12B4
- Conditions
- Alveolar Childhood Rhabdomyosarcoma, Childhood Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research trial studies biomarkers in tumor tissue samples from younger patients with rhabdomyosarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer
Detailed description
PRIMARY OBJECTIVES:
- To demonstrate CRKL expression at the protein level in rhabdomyosarcoma tumors by tissue microarray (TMA).
OUTLINE:
Archived tumor tissue samples are analyzed for CRKL expression.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science (biomarker analysis) | – | Other: laboratory biomarker analysisArchived tumor tissue samples are analyzed for CRKL expression. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma
Key inclusion criteria (1 listed)
- Alveolar rhabdomyosarcoma and embryonal rhabdomyosarcoma specimens from the Children Oncology Group (COG) tumor microarrays (TMAs)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysisCorrelative studies | Other | Basic science (biomarker analysis) |
Primary outcome
CRKL expression at the protein level
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
Related trials for Alveolar Childhood Rhabdomyosarcoma
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Active, not recruitingPhase 2
Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma
Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Helman, MD principal investigator
Children's Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alveolar Childhood Rhabdomyosarcoma and Childhood Rhabdomyosarcoma, run by Children's Oncology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRKL expression at the protein level (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.